pramoxine/hydrocortisone lotion - topical, Pramosone (cont.)

HOW TO USE: Follow all instructions in the product package, including any instructions for cleaning the container after use. Before each use, shake the foam canister well for 5-10 seconds. Before applying the medication, clean the affected area with mild soap and water, rinse well, and pat dry. Apply a small amount of the foam to the affected area, usually 3-4 times a day or as directed by your doctor. You may need to press the applicator a few times before foam appears. You can apply the foam directly to the area, or apply a small amount to a pad and use it to apply the foam to the affected area. Do not use the foam or insert any part of the foam canister in the anus or vagina.This medication is for use on the skin only, as directed by your doctor. Do not use more of this product, use it more often, or keep using it longer than prescribed because doing so may increase the risk of side effects. Wash hands immediately after use, unless the area being treated includes the hands. Avoid getting the product in your eyes, nose, ears or mouth. If the medication gets in these areas, rinse the area immediately with clean water.Do not cover the area with waterproof bandages or plastic, apply heat, or use the product on large areas of the body unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants. These may increase the risk of side effects.How often the medication is applied and for how long depends on your condition and response to treatment. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day.If you have been using this medication for a long time or in high doses, do not suddenly stop using it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition does not improve or if it worsens.

SIDE EFFECTS: Redness, burning, or itching at the application site may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: change in skin appearance (e.g., color, thickness), signs of skin infection (e.g., feeling of heat at the area, tenderness, pus).Tell your doctor immediately if any of these rare but very serious side effects occur: signs of serious infection (e.g., fever, persistent sore throat).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.